Liver

[PamMB]

I just found out that Bistol-Myers issued a warning (in January) about a much higher incidence of liver failure for patients being treated with Serzone.  I haven't been able to find much more info about this issue, but am concerned since I do take 200mg of Serzone every day.  The only time I had some liver abnornalities was when I had a very high liver enzyme count last year, but that was shortly after I had a gall-bladder attack (my doctor attributed the high liver enzymes to the attack).  I will be discussing this issue with my physician, but is there any additional info concerning this latest warning about Serzone and liver failure?  How serious does an issue have to be in order for a warning like this to be issued?

[SoulVygr]

I never had liver problems until I began taking Serzone.  I stopped on my own accord due to bizzare health issues.  It has been almost 5 months now and I still have intense pain to the point of crying.  The Dr. who recommended it denys that this product would effect me to the extent it has.  My problem is not gallbaldder related.  I have done 3 liver cleanses over the last 5 months and still can not irradicate the damage.  DON'T TAKE SERZONE.

[imkindly]

This is from the FDA page at
http://www.fda.gov/medwatch/SAFETY/2001/dec01.htm

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SERZONE (nefazodone HCl) Tablets
[December 4, 2001: Bristol-Myers Squibb Company]


[Other labeling changes not appearing in 2001 PDR: http://www.fda.gov/medwatch/SAFETY/2001/mar01.htm#serzon, http://www.fda.gov/medwatch/SAFETY/2001/jan01.htm#serzon]


Addition of boxed warning:
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Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE.

The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000